CurrentCignaPolicy N/A

Tadalafil (Cialis) Prior Authorization Policy

Defines Cigna's prior authorization requirements and coverage criteria for tadalafil (Cialis and generic) for FDA-approved indications and selected other uses with supportive evidence; applies to prescription benefit plans administered by Cigna companies.

Policy Summary

PayerCigna

PolicyTadalafil (Cialis) Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateNov 6, 2024

Key ActionObtain prior authorization and document required prior drug trials or specialist consultation per indication before approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

FDA+selectIndications covered

1 yrTypical approval duration

NCGoverning state

No changesHistory note

Coverage Criteria for Tadalafil (Cialis)

Benign Prostatic Hyperplasia

Policy Summary

PayerCigna

PolicyTadalafil (Cialis) Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateNov 6, 2024

Key ActionObtain prior authorization and document required prior drug trials or specialist consultation per indication before approval.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Other Supported Uses

Other uses with supportive evidence (each listed use has its own required conditions).

High‑Altitude Pulmonary Edema (HAPE), treatment or prevention: Approve for 1 year in patients who meet BOTH of the following: A) Patient has HAPE or a history of HAPE; AND B) Patient has tried one other pharmacologic therapy for treatment or prevention of HAPE (examples include nifedipine, salmeterol (Serevent), dexamethasone, acetazolamide, sildenafil).both conditions

Policy lists doxazosin and terazosin among alpha agents; examples of other therapies provided in source.

Prophylaxis after radical prostatectomy (Early penile rehabilitation): Approve for 1 year in patients who meet BOTH of the following: A) Patient had radical prostatectomy within the previous 12 months; AND B) The medication is prescribed by or in consultation with an urologist.both conditions

Specialist prescribing/consultation required per policy.

Pulmonary arterial hypertension (PAH): Approve for 1 year in patients who cannot use Adcirca because the required tadalafil dose is not available with Adcirca (specifically patients using 10 mg doses). Note: patients using 20 mg or 40 mg for PAH should use Adcirca.dose‑based exception

Approve only when Adcirca cannot provide the needed dose (10 mg).

Raynaud's phenomenon: Approve for 1 year if the patient meets ONE of the following: A) Patient has tried one calcium channel blocker (examples: amlodipine, felodipine, nifedipine); OR B) Per prescriber, use of a calcium channel blocker is contraindicated.1 of 2

Examples of contraindications include right heart failure or decreased cardiac output.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior Authorization (PA) is required for prescription benefit coverage of tadalafil. Approvals are provided for the durations noted in the policy (typically 1 year for listed indications). Some approvals require the medication to be prescribed by or in consultation with a specialist in the condition being treated (see specialist/consultation callout).

All tadalafil requests require prior authorization.
Typical approval duration: 1 year for FDA‑approved and supported uses unless otherwise specified.

Step Therapy

Step Therapy / Prior Drug Trial Requirements

Step therapy / prior drug trial requirements: For the FDA‑approved indication of benign prostatic hyperplasia (BPH), the member must have tried ONE of the following prior to approval: an alpha‑1 (α1) blocker (examples: tamsulosin, alfuzosin, doxazosin, terazosin) OR a 5α‑reductase inhibitor (examples: finasteride, dutasteride). For high‑altitude pulmonary edema (HAPE) treatment or prevention, the member must have tried one other pharmacologic therapy (examples: nifedipine, salmeterol, dexamethasone, acetazolamide, sildenafil). For Raynaud’s phenomenon, the member must have tried a calcium channel blocker (examples: nifedipine, amlodipine, felodipine) unless contraindicated per prescriber.

BPH: trial of an alpha‑1 blocker (e.g., tamsulosin, alfuzosin) OR a 5α‑reductase inhibitor (e.g., finasteride, dutasteride).
HAPE: trial of one other pharmacologic therapy (e.g., nifedipine, salmeterol, dexamethasone, acetazolamide, sildenafil).
Raynaud’s: trial of a calcium channel blocker (e.g., nifedipine, amlodipine, felodipine) or documentation that a calcium channel blocker is contraindicated.

Documentation Required

Specialist Prescribing / Consultation Required

Specialist Prescribing/Consultation: Because of the specialized skills required for evaluation, diagnosis, and monitoring of patients treated with tadalafil, some approvals require the medication to be prescribed by or in consultation with a specialist (for example, a urologist for post‑radical prostatectomy prophylaxis). Ensure documentation of specialist involvement when required.

Prophylaxis after radical prostatectomy: medication must be prescribed by or in consultation with a urologist.
Document specialist consultation or prescriber specialty on the PA request when the indication list specifies a specialist requirement.

Denial Risk

Experimental / Unproven Uses Not Covered

Experimental/Unproven Uses Not Covered: Tadalafil (Cialis and generics) is considered experimental, investigational, or unproven for any uses not listed in the policy. Requests for indications outside the listed FDA‑approved or evidence‑supported uses are subject to denial.

Denial risk for requests outside listed indications — clinical rationale and supporting literature will be required to consider exceptions.

Product Codes, Dosage Forms, and Related Coding

Covered productsmixedCovered

N/A	Tadalafil tablets (Cialis, generic) — product referenced; no procedure codes listed

Dosage tablets available

Tablet strengths2.5 mg, 5 mg, 10 mg, 20 mg

FormulationOral tablets (Cialis, generic)

Active ingredientTadalafil (phosphodiesterase type 5 inhibitor)

PAH dosing exception

PAH dosing exceptionApprove tadalafil when a 10 mg dose is required and Adcirca cannot provide that dose (patients using 10 mg of Cialis/generic)

Adcirca dosing notePatients using 20 mg or 40 mg for PAH should use Adcirca

Approval durationApprove for 1 year when exception criteria met

Background

Tadalafil (Cialis, generic) is a phosphodiesterase type 5 (PDE5) inhibitor with approved indications that include treatment of benign prostatic hyperplasia (BPH) and erectile dysfunction (ED), and combined ED with BPH. It has also been studied for other conditions such as high‑altitude pulmonary edema (HAPE), pulmonary arterial hypertension (PAH), prophylaxis after radical prostatectomy (early penile rehabilitation), and Raynaud’s phenomenon; these other uses are addressed in the policy where supportive evidence exists.

Definitions and Terms

Tadalafil (Cialis, generic)

DefinitionTadalafil (Cialis, generic) — a phosphodiesterase type 5 (PDE5) inhibitor used for BPH, erectile dysfunction, and combined ED with BPH

Available tablet strengths2.5 mg, 5 mg, 10 mg, 20 mg

Clinical study usesStudied for HAPE, prophylaxis after radical prostatectomy, PAH, and Raynaud's phenomenon

Prophylaxis after radical prostatectomy

DefinitionEarly penile rehabilitation (prophylaxis after radical prostatectomy) — prophylactic tadalafil use within the previous 12 months after radical prostatectomy to aid erectile function recovery

Timing requirementPatient had radical prostatectomy within the previous 12 months

Prescriber requirementMedication must be prescribed by or in consultation with a urologist